A John Camm1, Pierre Amarenco2, Sylvia Haas3, Susanne Hess4, Paulus Kirchhof5, Marc Lambelet6, Miriam Bach4, Alexander G G Turpie7. 1. Cardiovascular and Cell Sciences Research Institute, St George's, University of London, London, UK. 2. Department of Neurology and Stroke Centre, Paris-Diderot-Sorbonne University, Paris, France. 3. Formerly Institute for Experimental Oncology and Therapy Research, Technical University of Munich, Germany. 4. Medical Affairs, Bayer AG, Berlin, Germany. 5. Institute of Cardiovascular Sciences, University of Birmingham, UHB and Sandwell and West Birmingham Hospitals NHS Trusts, Birmingham, UK. 6. Chrestos Concept GmbH & Co. KG, Essen, Germany. 7. Department of Medicine, McMaster University, Hamilton, ON, Canada.
Abstract
AIMS: Based on Phase III data, non-vitamin K antagonist oral anticoagulants are recommended for stroke prevention in patients with atrial fibrillation. To determine whether trial outcomes translate into similar event rates in unselected patients, this analysis compared outcomes from the real-world XANTUS study with those from the Phase III ROCKET AF study. METHODS AND RESULTS: Individual patient data from 4020 XANTUS patients were re-weighted to match the proportion of selected baseline characteristics in 7061 rivaroxaban-treated patients from ROCKET AF, using the matching-adjusted indirect comparison (MAIC) method. For the primary analysis, CHADS2 scores and gender were selected as relevant variables. Adjusted annualized incidence rates for XANTUS were calculated and compared with incidence rates from ROCKET AF-the ratio of these rates ('MAIC ratio') was used as a relative effect estimate. Rates of major bleeding [3.10%/year vs. 3.60%/year; MAIC ratio 0.86; 95% confidence interval (CI) 0.67-1.12] and stroke/non-central nervous system systemic embolism (1.54%/year vs. 1.70%/year; MAIC ratio 0.91; 95% CI 0.62-1.32) were similar between XANTUS and ROCKET AF. The rate of all-cause death was higher in XANTUS (3.22%/year vs. 1.87%/year; MAIC ratio 1.72; 95% CI 1.31-2.27), but the rates of vascular death were similar (1.83%/year vs. 1.53%/year; MAIC ratio 1.19; 95% CI 0.84-1.70). Sensitivity analyses weighted by different baseline characteristics supported these results. CONCLUSION: The low rates of major bleeding and stroke in XANTUS were consistent with results from ROCKET AF. All-cause death, but not vascular death, was higher in XANTUS, as expected in an unselected real-world population. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIMS: Based on Phase III data, non-vitamin K antagonist oral anticoagulants are recommended for stroke prevention in patients with atrial fibrillation. To determine whether trial outcomes translate into similar event rates in unselected patients, this analysis compared outcomes from the real-world XANTUS study with those from the Phase III ROCKET AF study. METHODS AND RESULTS: Individual patient data from 4020 XANTUS patients were re-weighted to match the proportion of selected baseline characteristics in 7061 rivaroxaban-treated patients from ROCKET AF, using the matching-adjusted indirect comparison (MAIC) method. For the primary analysis, CHADS2 scores and gender were selected as relevant variables. Adjusted annualized incidence rates for XANTUS were calculated and compared with incidence rates from ROCKET AF-the ratio of these rates ('MAIC ratio') was used as a relative effect estimate. Rates of major bleeding [3.10%/year vs. 3.60%/year; MAIC ratio 0.86; 95% confidence interval (CI) 0.67-1.12] and stroke/non-central nervous system systemic embolism (1.54%/year vs. 1.70%/year; MAIC ratio 0.91; 95% CI 0.62-1.32) were similar between XANTUS and ROCKET AF. The rate of all-cause death was higher in XANTUS (3.22%/year vs. 1.87%/year; MAIC ratio 1.72; 95% CI 1.31-2.27), but the rates of vascular death were similar (1.83%/year vs. 1.53%/year; MAIC ratio 1.19; 95% CI 0.84-1.70). Sensitivity analyses weighted by different baseline characteristics supported these results. CONCLUSION: The low rates of major bleeding and stroke in XANTUS were consistent with results from ROCKET AF. All-cause death, but not vascular death, was higher in XANTUS, as expected in an unselected real-world population. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Carlo Lavalle; Marco Valerio Mariani; Agostino Piro; Michele Magnocavallo; Giampaolo Vetta; Sara Trivigno; Giovanni Battista Forleo; Domenico Giovanni Della Rocca; Massimo Uguccioni; Vincenzo Russo; Francesco Summaria; Luca Di Lullo Journal: J Clin Med Date: 2022-06-04 Impact factor: 4.964
Authors: Anda Bularga; Mohammed N Meah; Dimitrios Doudesis; Anoop S V Shah; Nicholas L Mills; David E Newby; Kuan Ken Lee Journal: Open Heart Date: 2021-07